a clinical study of hetrombopag olamine tablets for thrombocytopenia induced by chemotherapy in advanced breast cancer

Conditions: Breast Cancer

Summary: this study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

chemotherapy-induced thrombocytopenia increases the risk of hemorrhagic complications, the need for platelet transfusions, and limits the dose of cytotoxic drugs in the treatment of certain malignancies. thrombopoietin receptor agonist (tpo-ra) has a therapeutic effect on chemotherapy-induced thrombocytopenia (cit). as an innovative tpo-ra drug, hetrombopag has a more optimized molecular structure and reduced liver and kidney toxicity. a registrational phase iii clinical study in cit patients is ongoing. this study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

Eligibility criteria:
inclusion criteria: 1. the patients signed the informed consent and voluntarily joined the study; 2. age 18-75 years old, male or female; 3. patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen; 4. can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles; 5. the first occurrence of platelets \<50×109/l in the current chemotherapy cycle; 6. the investigator determines that the patient can receive hetrombopag administration; 7. neutrophil count ≥ 1.0×109/l, hemoglobin ≥ 80g/l before administration of haitrombopag; 8. life expectancy at screening ≥ 12 weeks; 9. ecog: 0-1; 10. the main organ functions are normal, and there are no serious complications. exclusion criteria: 1. women who are pregnant or breastfeeding; 2. unable to understand the research nature of the research or have not obtained informed consent; 3. the investigator judges other circumstances that are not suitable for inclusion in the study; 4. thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); 5. patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction; 6. those with a history of blood disease or tumor bone marrow infiltration; 7. those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past; 8. arterial or venous thrombotic events within the past 6 months; 9. there are currently uncontrollable infections; 10. clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding; 11. need emergency treatment, such as superior vena cava syndrome, spinal cord compression; 12. the absolute value of neutrophils is less than 1.0×109/l, and the hemoglobin is less than 80g/l, and granulocyte colony-stimulating factor, red blood cells, and epo infusion therapy in accordance with clinical routine are allowed; 13. obvious abnormal liver function: patients without liver metastases, alt/ast\>3uln (upper limit of normal value), tbil\>3uln; patients with liver metastases, alt/ast≥5uln, tbil≥5uln; 14. abnormal renal function: serum creatinine ≥ 1.5uln or egfr ≤ 60 ml/min (cockcroft-gault formula); 16. received thrombopoietin receptor agonist drugs (such as eltrombopag, romigrastim), or recombinant human thrombopoietin (rhtpo), recombinant human interleukin-11 (rhil) within 1 month before screening -11) treatment; 17. received platelet transfusion within 3 days before randomization; 18. patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of hetrombopag ethanolamine tablets.